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Re: None

Wednesday, 01/11/2017 2:01:15 AM

Wednesday, January 11, 2017 2:01:15 AM

Post# of 10347
Heard the webcast...everyone knew end of Q4 for CE was 'best' case, and not likely. He is still targeting Q1 as he discussed in Oct last year. Plan is still the same. Just waiting for 3rd party to approve etc. so there has been good process.
Timeline is still the same. Q1 submission.

FDA discussion is definitely new news, and very positive. IDE for internal trails...is that being done for US ? Meaning the internal trials will be done in the US vs. Europe ?